FDA Drug Services Requirements
FDA Defines Drugs as One of the Following:
- A substance recognized by an official pharmacopoeia or formulary
- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
- A substance (other than food) intended to affect the structure or any function of the body.
- A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Most drugs must be approved by FDA under a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) or be generally recognized as safe and effective (GRASE) by qualified experts.
In addition, the following requirements must be met to legally market a drug in the United States:
FDA Drug Compliance Services
Expert FDA Compliance Services - We Handle the Complexity
Meeting FDA requirements is mandatory – but navigating them doesn’t have to be overwhelming. Our experts ensure you’re compliant from day one. Our services include:
Drug Facility Registration
- FDA registration of drug establishments including manufacturers, re-packers, and re-labelers.
Drug Listing
- Obtain drug listing number also known as the National Drug Code (NDC) which is required for drugs for commercial use.
Label Review
- Report detailing all changes that must be made to bring the label into compliance with U.S. federal regulations.
Regulatory Review
- Full report explaining the federal regulatory requirements such as requirements for ingredients, doses, and formulation. We identify any potential problems marketing the product in the US – and advise how to resolve or prevent those problems.
FDA Drug Compliance Requirements
FDA Drug Requirements
Establishment Registration
Any establishment that manufactures, repacks, relabels, or salvages a drug for distribution in the US must be registered with FDA as a drug establishment. Companies that only import drugs (do not perform any of the above activities) do not need to register with FDA.
Drug Listing
A registered drug establishment must list each of its drugs with FDA. Each listed drug is assigned a National Drug Code (NDC) which includes a labeler code. The labeler code is the portion of the NDC that represents the establishment (not to be confused with the establishment’s registration number). If the brand owner of the drug uses a contract manufacturing organization (CMO), the drug must have two NDCs –one containing the labeler code for the CMO and one with the labeler code for the brand owner. For importing a drug, the Customs filer/broker must submit the NDC number to FDA and Customs when filing the entry.
Labeling Compliance
Labels of OTC drugs must comply with FDA’s drug labeling requirements such as having a properly declared statement of identity, net quantity of contents, name and place of business (manufacturer, packer, or distributor), expiration date, and a Drug Facts panel which states the active ingredient, uses, warnings, inactive ingredients, purpose, directions, and contact information. Labels of prescription drugs must bear the drug’s name, dosage form and strength, route of administration, directions for safe use, applicable warning statements, indications and usage, contraindications, and other information.
Over-The-Counter (OTC) Drugs
Drugs must be manufactured and packed in accordance with Good Manufacturing Practices (GMPs). The GMPs cover the facilities, methods, and controls used for the manufacturing of the drugs to ensure the products meet requirements for the safety, identity, strength, quality, and purity of the drugs.
OTC Homeopathic Drugs
FDA defines a homeopathic drug as a drug that is labeled as “homeopathic” and which contains active ingredients in dilutions listed in the Homeopathic Pharmacopeia of the United States (“HPUS”). Currently, FDA has not legalized any homeopathic drugs (contrary to widely held belief). However, FDA is exercising enforcement discretion in focusing its enforcement activities on homeopathics that are reported to have caused injury and raise potential safety concerns, homeopathics intended to prevent or treat a serious disease or condition, and certain other homeopathic products
Good Manufacturing Practices (GMPs)
Drugs must be manufactured and packed in accordance with Good Manufacturing Practices (GMPs). The GMPs cover the facilities, methods, and controls used for the manufacturing of the drugs to ensure the products meet requirements for the safety, identity, strength, quality, and purity of the drugs.
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Expert Regulatory Reports & Label Review
Identify Compliance Issues Before FDA Does
Regulatory Report
Receive a full report explaining the federal regulatory requirements such as requirements for ingredients, doses, formulation for your drug product and identifying any potential problems in marketing the product in the US – and advising how to resolve or prevent those problems.
Label Review
Receive a full report listing all changes that must be made to bring the drug label into compliance with U.S. federal regulations. We also offer label design services as well.
How We Get You FDA Compliant - Fast
01
Free Consultation
We provide an initial consultation of up to 30 minutes by phone of video conference for no charge. No obligation, no pressure.
02
Friendly Honest Service
Speak to real FDA experts, not merely sales associates or other non-experts. No tedious sales pitches or attempts to sell you any unnecessary services.
03
We Handle Everything
Receive a detailed action plan with timeline, costs, and specific steps needed for your products.
04
Import with Confidence
Your imported shipments clear the ports smoothly with all FDA requirements met. We provide ongoing support as regulations evolve.